Department of Anaesthesia and Pain Management, Royal Melbourne Hospital, Parkville, Victoria 3050, Australia.
Anesth Analg. 2010 Mar 1;110(3):816-22. doi: 10.1213/ANE.0b013e3181c3bfb2. Epub 2009 Nov 12.
When anesthesia is titrated using bispectral index (BIS) monitoring, patients generally receive lower doses of hypnotic drugs. Intraoperative hypotension and organ toxicity might be avoided if lower doses of anesthetics are administered, but whether this translates into a reduction in serious morbidity or mortality remains controversial. The B-Aware Trial randomly allocated 2463 patients at high risk of awareness to BIS-guided anesthesia or routine care. We tested the hypothesis that the risks of death, myocardial infarction (MI), and stroke would be lower in patients allocated to BIS-guided management than in those allocated to routine care.
The medical records of all patients who had not died within 30 days of surgery were reviewed. The date and cause of death and occurrence of MI or stroke were recorded. A telephone interview was then conducted with all surviving patients. The primary end point of the study was survival.
The median follow-up time was 4.1 (range: 0-6.5) years. Five hundred forty-eight patients (22.2%) had died since the index surgery, 220 patients (8.9%) had an MI, and 115 patients (4.7%) had a stroke. The risk of death in BIS patients was not significantly different than in routine care patients (hazard ratio = 0.86 [95% confidence interval {CI}: 0.72-1.01]; P = 0.07). However, propensity score analysis indicated that the hazard ratio for death in patients who recorded BIS values <40 for >5 min compared with other BIS-monitored patients was 1.41 (95% CI: 1.02-1.95; P = 0.039). In addition, the odds ratios for MI in patients who recorded BIS values <40 for >5 min compared with other BIS-monitored patients was 1.94 (95% CI: 1.12-3.35; P = 0.02) and the odds ratio for stroke was 3.23 (95% CI: 1.29-8.07; P = 0.01).
Monitoring with BIS and absence of BIS values <40 for >5 min were associated with improved survival and reduced morbidity in patients enrolled in the B-Aware Trial.
当使用双频谱指数（BIS）监测来滴定麻醉时，患者通常会接受较低剂量的催眠药物。如果给予较低剂量的麻醉剂，可能会避免术中低血压和器官毒性，但这是否会降低严重发病率或死亡率仍存在争议。B-Aware 试验将 2463 名有发生意识障碍风险的患者随机分配至 BIS 指导麻醉或常规护理。我们检验了以下假说，即与接受常规护理的患者相比，接受 BIS 指导管理的患者的死亡、心肌梗死（MI）和中风风险更低。
回顾所有术后 30 天内未死亡的患者的病历。记录死亡日期和原因，以及 MI 或中风的发生情况。然后对所有存活患者进行电话访谈。研究的主要终点为生存。
中位随访时间为 4.1 年（范围：0-6.5 年）。自指数手术后 548 例患者（22.2%）死亡，220 例患者（8.9%）发生 MI，115 例患者（4.7%）发生中风。BIS 患者的死亡风险与常规护理患者无显著差异（风险比=0.86[95%置信区间{CI}：0.72-1.01]；P=0.07）。然而，倾向评分分析表明，与其他 BIS 监测患者相比，BIS 值<40 且持续时间>5 分钟的患者死亡风险比为 1.41（95%CI：1.02-1.95；P=0.039）。此外，与其他 BIS 监测患者相比，BIS 值<40 且持续时间>5 分钟的患者发生 MI 的比值比为 1.94（95%CI：1.12-3.35；P=0.02），发生中风的比值比为 3.23（95%CI：1.29-8.07；P=0.01）。
在 B-Aware 试验中，BIS 监测和不存在 BIS 值<40 且持续时间>5 分钟与患者的生存改善和发病率降低相关。
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